A Proactive Walking Trial to Reduce Pain in Black Veterans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- 30% Improvement in Physical Functioning as Assessed by the Roland Morris Disability Questionnaire [RMDQ]) at 6 Months
研究概览
简要总结
The long term goal is to improve the quality and equity of chronic pain treatment among VA patients. The primary objective of this study is to improve pain outcomes among black VA patients with chronic, musculoskeletal (MSK) pain, who experience poorer pain treatment and outcomes than their white counterparts. The work proposed is expected to result in a non-pharmacological intervention, delivered by telephone, designed to reduce pain and improve functioning among black patients with MSK pain, by promoting walking. This intervention is specifically designed to address factors that contribute to MSK pain among black Veterans; however, the investigators expect that it will also benefit non-black Veterans. The proposed research is innovative, in its use of proactive outreach and recent advances in self-regulation strategies (such as Action Planning) to help black Veterans overcome psychological, environmental, utilization-related, and provider-related barriers that contribute to pain.
详细描述
BACKGROUND/RATIONALE:
Chronic musculoskeletal (MSK) pain is one of the most common conditions among Veterans, affecting approximately 60% of those seen in VA primary care. Although perceived effectiveness of chronic pain treatment is low among all VA patients, black patients are less likely than whites to perceive their treatment as effective, and are more likely to experience functional limitations due to pain. There is growing consensus that chronic pain is best addressed by a biopsychosocial approach that acknowledges the role of psychological and environmental contributors to pain, some of which differ by race and hence contribute to disparities. For example, blacks experience greater pain-related fear and lower self-efficacy in coping with pain (psychological contributors), and neighborhoods that make physical activity difficult (environmental contributors). However, there is a lack of effective interventions to improve pain treatment among minority patients, particularly those that target psychological and environmental contributors.
OBJECTIVES:
The long term goal is to improve the quality and equity of pain treatment in order to improve pain outcomes for all Veterans. The objective of this application is to test the effectiveness of a multi-component intervention that specifically targets known barriers to effective pain care among black Veterans with chronic MSK pain. The primary hypothesis is that a telephone-delivered intervention, which emphasizes walking and incorporates Action Planning, Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT) techniques, and the use of pedometers, will improve core chronic pain outcomes in black Veterans. Secondarily, we will determine whether our intervention also benefits non-black patients with MSK.
METHODS:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients must receive care at the Atlanta VAMC and
- •have back, hip or knee pain for a duration of at least 6 months,
- •moderate-severe pain intensity and interference with function (defined as a PEG score of 5 or greater),
- •self-reported ability to walk at least 1 block, and
- •must be able to communicate effectively by telephone (no cognitive disability). The investigators will not exclude patients who are on medication or receiving interventions to treat their chronic pain. The investigators will include the approximately 10% of patients who have no race data; race data will be collected on the brief screening survey.
排除标准
- •The investigators will not include any vulnerable populations or those who meet any of the following exclusion criteria that may interfere with the outcome assessment: a) moderately severe cognitive impairment defined as > 2 errors on a brief cognitive screener; b) anticipated back, knee, hip, or other major surgery within the next 6 months; c) patients who say they are unable to walk at least a block; d) patients who say they would be unavailable to participate in a 6 month study; e) patients with active psychotic symptoms, suicidality, and/or active manic episode or poorly controlled bipolar disorder, as determined by chart review.
结局指标
主要结局
30% Improvement in Physical Functioning as Assessed by the Roland Morris Disability Questionnaire [RMDQ]) at 6 Months
时间窗: Assessed at baseline and 6 months
30% improvement on the Roland Morris Disability Questionnaire \[RMDQ\]) from baseline over the 6-month follow-up period. Minimum value: 0. Maximum value: 11. Higher scores indicate greater disability.
次要结局
- Change in Generalized Anxiety Disorder at 6 Months(Baseline and 6 months)
- Overall Improvement Assessed by Patient Global Impression of Change Scale at 6 Months(6 months)
- 30% Improvement in Physical Functioning as Assessed by the Roland Morris Disability Questionnaire [RMDQ]) at 3 Months(Baseline and 3 months)
- Change in Brief Pain Intensity Scale at 6 Months(Baseline and 6 months)
- Change in Depression at 6 Months(Baseline and 6 months)
- Mean Change in Average Daily Total Steps at 6 Months(baseline and 6 months)
- Change in Depression Using 3 Month(Baseline and 3 months)
- Mean Change in Average Daily Total Steps, at 3 Months(3 months)
- Change in Brief Pain Intensity Scale at 3 Months(Baseline and 3 months)
- Change in Generalized Anxiety Disorder, at 3 Months(Baseline and 3 months)
- Overall Improvement Assessed by Patient Global Impression of Change Scale at 3 Months(3 months)